Effects of a multicomponent sleep enhancement protocol on delirium incidence in elderly critically ill surgical patients: a randomized controlled trial.
Nuanprae Kitisin, Suchanun Lao-Amornphunkul, Nattachai Hemtanon, Napat Thikom, Nawarat Phochan, Chayanan Thanakiattiwibun, Onuma Chaiwat, Karuna Wongtangman, Paranee Trachuthamcharoen, Annop Piriyapatsom, Laurence Weinberg, Ary Serpa Neto, Nattaya Raykateeraroj
Abstract
Open AccessBACKGROUND: Sleep disturbances are common in critically ill patients and increase delirium risk, leading to worse outcomes. Non-pharmacologic sleep interventions show mixed results, with limited randomized controlled trial (RCT) data in surgical ICU populations. METHODS: We conducted a prospective, single-blind randomized controlled trial in a surgical ICU to evaluate a multicomponent sleep enhancement protocol vs. usual care in patients aged ≥ 65 years with expected ICU stays > 24 h. The intervention included environmental modifications (noise and light reduction, closed doors, alarm adjustments) and patient-specific measures (earplugs, eye masks). Delirium incidence over 7 days was assessed using the Thai version of CAM-ICU by blinded evaluators. Sleep quality was measured daily with the Richards-Campbell Sleep Questionnaire (RCSQ). Bayesian methods estimated treatment effects and posterior probabilities of benefit. RESULTS: Of 177 patients analyzed (89 intervention, 88 control), delirium occurred in 10.1% of the intervention group vs. 17.0% in controls (Bayesian OR 0.55; 95% credible interval [CrI] 0.22-1.31; posterior probability of benefit 90.6%). In a predefined high-risk subgroup, delirium incidence was 14.0% vs. 30.0% (OR 0.38; 95% CrI 0.12-1.83; posterior probability of benefit 95.7%). Sleep quality scores and clinical outcomes did not differ significantly. Adherence was high for environmental modifications but moderate for earplugs and eye masks. CONCLUSIONS: Among elderly surgical ICU patients, a multicomponent, non-pharmacologic sleep enhancement protocol was associated with a high posterior probability of reducing delirium during the early ICU period, despite no measurable improvement in subjective sleep quality. The findings are hypothesis-generating; given the protocol's simplicity and low risk, confirmation in larger multicenter trials with objective sleep measures and strategies to optimize adherence is warranted. TRIAL REGISTRATION: This study was registered with the Thai Clinical Trials Registry (TCTR: https://www.thaiclinicaltrials.org ) under the registration number TCTR20221129003, with the registration date of 29 November 2022. TCTR20221129003.